ES3015111T3 - Ocular microcurrent stimulation therapy apparatus - Google Patents

Abstract

Devices and methods for administering microcurrent stimulation therapy to the human body, by connecting to a microstimulation current generating apparatus. The method consists of applying microcurrent stimulation therapy to key points around the eye for the treatment of conditions such as macular degeneration, retinitis pigmentosa, glaucoma, optic neuritis, and other ocular or nerve conditions, as well as other diseases, such as Bell's palsy, that require localized stimulation in the eyes or other parts of the body. An apparatus is provided, comprising a disposable therapy device including a strip of material or substrate containing a plurality of electrodes configured to apply a microcurrent stimulation therapy to a patient, wherein the substrate is shaped to be positioned to place electrodes on at least one of an upper eyelid and a lower eyelid of the patient's skin for a treatment session, and wherein each of the plurality of electrodes is configured to be individually activatable for microcurrent stimulation such that one or more of the plurality of electrodes are selectively activated at a time without activation of any other of the plurality of electrodes during that time. (Automatic translation with Google Translate, without legal value)

Description

DESCRIPTION

Ocular microcurrent stimulation therapy device

Field of the invention

The present invention relates to devices for electrically stimulating animal tissue, and in particular to a microstimulation electrode apparatus that delivers microcurrent stimulation therapy to the human body, when connected to a microstimulation current generating apparatus. The present invention further relates to a way of applying microcurrent stimulation therapy to key points around the eye for the treatment of diseases such as macular degeneration, retinitis pigmentosa, glaucoma, optic neuritis, optic neuropathy, diabetic retinopathy, macular edema, papilledema and other eye or nerve related diseases, as well as other diseases, such as Bell's palsy, that require localized stimulation in other parts of the body.

Background of the invention

Chronic pain is a problem for millions of people around the world. One procedure for treating such pain is to provide microcurrent stimulation around or near the areas where the pain occurs. Microcurrent, which is generally defined as a current below one (1) milliamp, can provide fast and long-lasting pain relief for a wide variety of pain syndromes. Generally, microcurrent stimulation therapy involves applying a current between 20 and 300 microamps (~20 to ~300 pA) to the affected area. The current blocks the neuronal transmission of pain signals and stimulates the release of endorphins, which helps relieve pain in patients with chronic and acute pain, as well as suppress the inflammatory response.

In addition to chronic pain relief, microcurrent therapy is used to treat various eye conditions, including macular degeneration, retinitis pigmentosa, macular edema, glaucoma, optic neuritis, Bell's palsy, and others. Secondary literature suggests that this microcurrent treatment stimulates blood flow, increases ATP (adenosine triphosphate) at the cellular level, and improves cell permeability. Furthermore, such stimulation is believed to restore functional neural pathways to the muscles and brain, as well as to blood vessels and the brain.

Age-related macular degeneration (AMD) is a very common eye disease, affecting more people than glaucoma. Macular degeneration is the most common cause of blindness in patients 60 years of age and older in the United States and is estimated to affect more than 10 million Americans. (Source: National Institutes of Health.) Macular degeneration causes deterioration of various retinal tissues in the macula, the most light-sensitive central area of the retina responsible for detailed central vision. Impaired blood circulation in the central retina, with corresponding partial to complete vision loss, is a typical consequence of macular degeneration.

Because there is currently no approved treatment for dry AMD, little research has been conducted on the market potential. However, there is significant data on the large number of people affected by AMD, and it is estimated to cause approximately 8.7% of blindness and low vision worldwide. According to a World Health Organization report, "AMD is the leading cause of blindness in developed countries and the third leading cause worldwide." The prevalence of AMD in Europe is estimated to be 16.3 million people (excluding Southeastern and Eastern Europe), and 10.2 million in the United States. This increases to a combined total of 41 million when Canada, Australia, New Zealand, Russia, and Japan are added. Ninety percent (90%) of these cases are dry AMD for which there is no currently approved treatment to restore vision.

Approximately 25% of the population (in target markets, ages 65 to 75) has AMD, and this increases to 35% for people 75 and older. Over the next 10 to 20 years, as baby boomers reach their sixties and older, the prevalence of the disease is projected to increase dramatically. In a study funded by the U.S. Centers for Disease Control and Prevention, researchers reported that as many as 9.1 million people in the U.S. had AMD in 2010, and 17.8 million would have it by 2050 (Rein et al., "Forecasting age-related macular degeneration through the year 2050: the potential impact of new treatments," Arch Ophthalmol. 2009 Apr;127(4):533-40. doi:10.1001/archophthalmol.2009.58).

The United States spends $2.7 trillion on healthcare each year, with vision care accounting for approximately three percent, or $60–70 billion, of the total. According to Eurostat, the European Union (EU) spends 45.7 percent of that amount, or about $1.23 trillion. Eye care spending is growing at six percent annually. According to the National Institutes of Health (NIH), it is expected to continue growing by at least six percent over the next few decades, driven by an aging population.

Macular degeneration causes an estimated $184 billion in lost productivity each year, and approximately $51 billion is spent on macular degeneration treatment each year in the United States. Ninety percent (90%) of macular degeneration cases are “dry,” or non-bleeding, called “atrophic AMD,” and approximately 10% of cases are “wet,” or bleeding, called “wet AMD.”

U.S. Patent 7,158,834 issued to Paul, Jr. on January 2, 2007, entitled "Method and Apparatus for Performing Microcurrent Stimulation (MSC) Therapy," describes a method and apparatus for providing microcurrent stimulation (MSC) therapy. Patent 7,158,834 states: The application of microcurrent signals at particular frequencies to the eye for particular periods of time has been determined to stabilize and even improve conditions of macular degeneration and other ocular diseases.

U.S. Patent 8,731,657 issued to Shambayati, et al. on May 20, 2014, titled "Multi-mode Microcurrent Stimulation System with Safety Circuitry and Related Methods," describes a microcurrent stimulation device with a power source, two or more electrodes electronically coupled to the power source, a microcontroller configured to generate an electromagnetic waveform, and an impedance measurement module configured to measure electrical impedance of one or more biological tissues between the two or more electrodes. A first safety circuit monitors the flow of electrical current through one or more components of the microcurrent stimulation device and interrupts the flow of electrical current if the flow of electrical current through the one or more components is above a predetermined level. A second safety circuit interrupts the flow of electrical current through the one or more components if a firmware failure occurs.

U.S. Patent 8,116,841 issued to Bly, et al. on February 14, 2012, entitled "Adherent Device Having Multiple Physiological Sensors," describes an adherent device for monitoring a patient over an extended period comprising a breathable tape. The breathable tape comprises a porous material with an adhesive coating for adhering the breathable tape to the patient's skin. At least one electrode is affixed to the breathable tape and is electrically coupled to the patient's skin. A printed circuit board is connected to the breathable tape for supporting the printed circuit board with the breathable tape when the tape is adhered to the patient. Electronic components are electrically connected to the printed circuit board and coupled to at least one electrode for measuring physiological signals from the patient. A breathable cover and/or an electronic housing are disposed over the circuit board and the electronic components and connected to at least one of the electronic components, the printed circuit board, or the breathable tape.

U.S. Patent 7,326,181 issued to Katims on February 5, 2008, entitled "Nerve Tissue Stimulation Device and Method," describes a method using a precisely controlled, computer-programmable stimulus for neuroselective tissue stimulation that does not leave sufficient voltage or electrical artifact in the tissue being stimulated that would interfere with or prevent a monitoring system from recording the physiological response. A computer controls both the waveform and the duration and intensity of the stimulus. An output trigger to the nerve response recording component controls the timing of its operation. A neuroselective nerve tissue response latency and amplitude can be determined. The computer-controlled stimulus can also be delivered for therapeutic purposes.

U.S. Patent 7,215,989 issued to Burks on May 8, 2007, entitled "Multiple Electrode Array," describes multiple electrode assemblies that provide an electrical connection between a patient's body and monitoring equipment. A multiple electrode array requires only half the number of assemblies as a conventional single electrode assembly to connect a patient to multiple pieces of equipment. Less time is required to connect the patient to the monitoring equipment. There is less discomfort for the patient since fewer assemblies are attached to the patient. The placement of fewer assemblies also leads to reduced cost. The assemblies can take a variety of different shapes and cable attachment configurations to accommodate a wide range of monitoring functions.

U.S. Patent 7,062,319 issued to Ihme, et al. on June 13, 2006, entitled "Method and arrangement for determining suitable treatment frequency and/or intensity," describes a method and arrangement for determining a suitable treatment frequency and/or intensity of a treatment signal used in electrical treatment. In the method, a stimulating electrical signal is directed at an object to produce different types of reaction in the object at different intensities of the stimulating electrical signal. For at least three different reaction types, the intensities of the stimulating electrical signal at which one type of reaction occurred are stored. The stored electrical signal intensities for the different reaction types at at least three different frequencies are compared to reference values, and the frequency and/or signal intensity at which the signal intensity sufficiently deviates from one or more reference values is determined. The method uses the frequency and/or signal intensity found in the process to determine the appropriate treatment frequency and/or signal intensity.

U.S. Patent 6,636,754 issued to Baura et al. on October 21, 2003, entitled "Apparatus and Method for Determining Cardiac Output in a Living Subject," describes an improved apparatus and method for determining the cardiac output of a living subject. The improved apparatus generally comprises one or more electrode arrays or patches affixed to the subject's skin in proximity to the thoracic cavity. The terminals of each electrode patch are in contact with an electrolyte gel and are separated a predetermined distance from each other within the patch. This predetermined separation allows for more consistent measurements and also allows for the detection of a loss of electrical continuity between the patch terminals and their associated electrical connectors in a clinical setting. The method generally comprises generating and passing a stimulating current through the terminals and the subject's thoracic cavity, and measuring the impedance over time. This impedance is used to determine the cardiac muscle's stroke volume, which is then used in conjunction with the subject's heart rate (also detected through the electrode patches) to determine cardiac output. A method for detecting a loss of electrical continuity at one or more of the electrode patch terminals is also described.

U.S. Patent 6,035,236, issued to Jarding, et al. on March 7, 2000, entitled “Methods and Apparatus for Electrical Microcurrent Stimulation Therapy,” describes an apparatus for delivering an electrical signal to a body portion for the purpose of providing microcurrent stimulation therapy to the body portion. The apparatus preferably comprises a first swept wave or swept frequency signal generator configured to generate a first swept wave signal, a regulating amplifier circuit configured to receive the first swept wave signal from the first swept signal generator and regulate and amplify the swept wave signal into a regulated swept wave signal. In addition, the apparatus preferably includes a current limiting circuit configured to receive the regulated swept wave signal from the regulating amplifier circuit and limit the amount of current delivered to the body portion. Finally, the apparatus preferably comprises a probe for applying the swept wave signal to the body portion. The apparatus may further comprise a second signal generator for generating a second signal that may comprise a swept wave signal or a non-swept wave signal. The apparatus may also include a signal combining circuit configured to receive the first and second signals from the first and second signal generators and combine the first and second signals into a composite swept wave signal.

U.S. Patent 6,275,735 issued to Jarding et al. on August 14, 2001, entitled "Methods and Apparatus for Electrical Microcurrent Stimulation Therapy," describes a method and apparatus for providing microcurrent stimulation therapy to a body part. In one embodiment, a method allows for digital control of the modulation frequency of the microcurrent signal. The method includes receiving a first digital data word that is used to produce a first frequency related to the first digital data word, after which a first microcurrent signal at the first frequency is applied to the body part. A second digital data word is received and used to produce a second frequency related to the second digital data word. A second microcurrent signal at the second frequency is applied to the body part. In another embodiment, a method allows for direct digital synthesis of the microcurrent stimulation signal. A first digital data word is used to produce a first analog voltage that is applied to the body part. A second digital data word is used to produce a second analog voltage that is also applied to the body part, where the first analog voltage is different from the second analog voltage. In yet another embodiment, an apparatus for providing microcurrent stimulation therapy includes a digital-to-analog converter, a controller, and a plurality of data words. The controller is coupled to the digital-to-analog converter and supplies the digital-to-analog converter with digital data words to generate an electrical signal for microcurrent stimulation therapy.

U.S. Patent Publication 2005/0137649 to Paul, Jr. published on June 23, 2005, titled "Method and Apparatus for Performing Microcurrent Stimulation (MCS) Therapy," describes a method and apparatus for providing microcurrent stimulation (MCS) therapy, and stated: "It has been determined that applying microcurrent signals at particular frequencies to the eye for particular periods of time stabilizes and even improves the conditions of macular degeneration and other ocular diseases and that experimental data from clinical trials show that the results of individuals who underwent therapy are at least better than placebo, and that the therapy is safe and effective. Patent Publication 2005/0137649 continued: Experimental data from clinical trials showed that approximately 98% of patients who underwent the MCS therapy of the invention experienced stabilization or improvement of macular degeneration within one year of beginning the therapy. Of this percentage, approximately 65% of patients undergoing MCS therapy experienced improved vision, while approximately 32% experienced stabilization of macular degeneration (i.e., no further vision loss).

U.S. Patent Publication 2008/0171929 to Katims published July 17, 2008, titled "Method for Standardizing Spacing Between Electrodes and Medical Tape Electrodes," discloses that standardization between paired electrodes is maintained in a medical device without the need for a Mylar spreader, such as by forming the paired electrodes integrally with a portion of the tape.

U.S. Patent 4,018,218 to Carlson et al. issued April 19, 1977, entitled "Method and Apparatus for Inducing Sleep," describes an apparatus and method for inducing sleep in a patient using an oscillator to control the frequency of electrical impulses received by the patient. The first and second multivibrators generate the signals necessary to stimulate the central nervous system by conduction through the optic nerve tract, and also to generate a visual aura caused by stimulation of the retina of the eye. An amplifier amplifies the signals generated by the multivibrators, and electrodes transmit the amplified signal to the patient. The various components of the apparatus may be stored in an ocular frame structure wherein the eyelid electrode pads are held in place adjacent to the patient's eyes, and wherein the mastoid electrode pads are held in place by frame ear hooks.

U.S. Patent 5,522,864 to Wallace et al. issued June 4, 1996, entitled "Apparatus and Method for Ocular Treatment," discloses that macular degeneration and other ocular pathology in a subject are treated by the steps of: placing a positive electrode of a direct current source in electrical contact with a closed eyelid of a subject; placing a negative electrode of the source in electrical contact with the subject's posterior neck; and causing a constant direct current of 200 pA to flow between the electrodes through the subject for approximately 10 minutes. The source may be a portable, battery-powered constant direct current generator that is attached to the subject. The subject may ambulate during treatment.

U.S. Patent 6,445,955 to Michelson et al. issued September 3, 2002, entitled "Miniature Wireless Transcutaneous Electrical Muscle Stimulation or Neurostimulation Unit," describes a miniature wireless transcutaneous electrical muscle stimulation or neurostimulation unit. The unit has a housing attached to a plurality of electrodes. An electronic module containing an electrical circuit is contained within the housing and delivers a sequence of monophasic or biphasic pulses to a patient's pain site via the electrodes. The electrodes may be disposable and come in a variety of shapes and sizes. The patient may select and control the intensity and frequency of the pulses by choosing one of several TENS and microcurrent waveforms, as well as the orientation and quantity of the electrodes. Means for supplying power to the electronics module may be integrated with the electrodes in a detachable, disposable assembly. A worn remote controller can send transmission signals to a receiver within the electronic module, allowing the patient to program specific units placed on the patient's body to perform operations in a specific series of waveforms. The electrodes may be embedded in a splint, bandage, brace, or cast, where wires or flexible circuit material connect the electrodes to the unit. The electrodes may be arranged in a grid-like manner to allow programming of a specific firing order that provides a greater therapeutic effect at a painful site, and they may also be embedded in adhesive strips, similar to a conventional Band-Aid.

US Patent 5,843,147 shows an electrode apparatus for implantation in an eyelid. US2006/069420 A1 shows a non-invasive magnetic and/or electrical remedy placed near the eye to reduce vision problems caused by floaters (a condition of the vitreous humor in the human eye). US Patent 2013/184782 A1 shows a device for electrostimulation of the eye, comprising a glasses-like support structure having a nose portion and an arrangement, connected to the nose portion, for holding the support structure on the patient's head, wherein at least one stimulation electrode is arranged in the nose portion. WO2014/110575 shows a system for stimulating facial expressions and movements, such as eye blinks, wherein an electrode support structure is fixed to the user's face by means of an electrically conductive adhesive.

What is still needed is an improved device to treat certain eye problems.

Summary of the invention

The present invention provides an apparatus according to claim 1. The dependent claims define further features and embodiments.

In some embodiments, the present invention applies microcurrent stimulation therapy to key points around the eye (and/or other parts of the body) for the treatment of diseases such as macular degeneration, retinitis pigmentosa, glaucoma, optic neuritis, optic neuropathy, diabetic retinopathy, macular edema, papilledema, and other eye- or nerve-related diseases, as well as other diseases, such as Bell's palsy, that require localized stimulation in other parts of the body.

The present invention may be used in an unclaimed method including: applying the disposable strip of material to the patient's skin; generating microcurrent pulses prescribed by the microcurrent stimulation controller; and delivering the microcurrent pulses to each respective one of the plurality of electrodes in a time sequence.

Brief description of the figures

Fig. 1A is a front view schematic diagram of a disposable ocular therapy apparatus strip system 101 having four disposable curved linear adhesive therapy strips 115 placed on the upper and lower eyelids of a person 99, showing exemplary electrode positions and connections to the treatment apparatus.

Fig. 1B is a front view of a system 102 showing an eye having two disposable adhesive therapy strips 115 each placed on the upper and lower eyelid of a person's eye 98, showing exemplary electrode positioning and connections to a microcurrent stimulation controller apparatus 161.

Fig. 1C is a side cross-sectional view of a disposable adhesive therapy strip 115.

Fig. 1D is an enlarged schematic cross-sectional view of a disposable adhesive therapy strip subsystem 140 including a removable cover 116.

Fig. 1E is an enlarged schematic cross-sectional view of a disposable adhesive therapy strip 145 without a removable cover 116.

Fig. 1F is an enlarged front schematic view of a disposable adhesive therapy strip subsystem 140. Fig. 1G is an enlarged cross-sectional schematic view of a disposable adhesive therapy strip subsystem 160.

Fig. 2A is a front view schematic diagram of an ocular therapy apparatus strip system 201 partially surrounding the eye, utilizing two individual adhesive therapy strips 215 with electrodes for the upper and lower eyelid showing the position of the electrodes and the cable to the microcurrent stimulation controller apparatus.

Fig. 2B is an enhanced detailed view of a system 202 on the upper and lower eyelid around eye 98 of a patient of the disposable partially surrounding ocular therapy apparatus strip 215 placed on the upper and lower eyelid showing the position of the electrodes and the connections to the microcurrent stimulation controller apparatus.

Fig. 2C is a side cross-sectional view of a disposable partially surrounding therapy apparatus strip 265.

Fig. 3A is a front view schematic diagram of two surrounding single-strip disposable therapy strips 310 forming a system 301.

Fig. 3B is an enhanced detail view of a system 302 on the upper and lower eyelid around eye 98 of a patient of the disposable around-the-eye therapy strip 310 placed on the upper and lower eyelid showing the position of the electrodes and the connections to the microcurrent stimulation controller apparatus. Fig. 3C is a side cross-sectional view of a disposable therapy strip 365.

Fig. 4A is a schematic diagram of the rear view of an eyeglass frame 401 having two surrounding strips 410.

Fig. 4B is a rear view schematic diagram of an eyeglass frame 402 having two surrounding straps 412 that fit the face.

Fig. 4C is a schematic diagram of the top side view of the eyeglass frame 402 having two surrounding strips 412 that fit the face.

Fig. 5A is a schematic diagram 560 of an exploded top side view of an eyeglass frame 560 having two disposable adhesive strips 511 surrounding the eyes that have not yet been joined together.

Fig. 5B is a schematic diagram of an assembled top side view of the eyeglass frame 561 having two disposable adhesive strips 515 attached surrounding the eye.

Fig. 6A is a front view schematic diagram of two semi-circle single-strip disposable therapy strips 615 forming a system 601.

Fig. 6B is a plan view diagram of a disposable electrode assembly 660 including a single semi-surround disposable therapy strip 615 and a single "ground" electrode 641.

Fig. 7 is a schematic block diagram of a therapy system 700 including a controller 701 and electrodes 715.

Fig. 8 is a schematic block diagram of a therapy system 800 including a controller 161 and light sensors 811.

Detailed description of the invention

Although the following detailed description contains many specific details for illustrative purposes, one of ordinary skill in the art will appreciate that many variations and alterations of the following details are within the scope of the invention as defined by the appended claims.

Furthermore, in the following detailed description of the preferred embodiments of the invention, reference is made to the accompanying drawings, which form a part of this invention, and which show by way of illustration specific embodiments in which the invention may be practiced. It is understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention as defined in the appended claims.

The initial digits of reference numbers appearing in Figures generally correspond to the Figure number where that component is first introduced, so the same reference number is used to refer to an identical component appearing in multiple Figures. Signals and connections may be referred to by the same reference number or label, and the actual meaning will be clear from its use in the context of the description.

Causes of AMD and Potential Treatment

The normal function of retinal cells is a photochemical reaction that converts light energy into an electrical impulse that travels to the brain, producing vision. With AMD and other visual system diseases, diseased and inflamed retinal cells eventually lose cellular function. Adenosine triphosphate (ATP) levels decrease, protein synthesis decreases, electrical resistance increases, and the electrical potential of the cell membrane decreases, limiting a cell's ability to move substrates in and out of a cell. Cells, without normal metabolic activity, remain temporarily inactive for a period of time before apoptosis.

It is believed that when electrical stimulation is delivered to cells before they die, blood vessel permeability increases, normal cellular electrical potential is restored or reached, ATP levels increase, protein synthesis resumes, regeneration of immature cells is activated, and normal cellular metabolism is restored, thereby improving or restoring visual function. Furthermore, in vitro studies have shown that electrical stimulation appears to have a healing effect on the small blood vessels of the retina, promoting a more efficient delivery of nutrients to retinal cells and more efficient removal of metabolic byproducts.

The retinal pigment epithelium (RPE) is the complex of supporting cells for the photosensitive rod and cone cells that make up the light-sensitive structure of the retina. The RPE is the first to be affected by impaired circulation. Once affected by poor circulation, the RPE cannot effectively assist the rods and cones in removing the byproducts of metabolic and photochemical responses, which are essential for cellular function. Yellowish subretinal deposits called "drusen" form when extracellular byproducts are not transported by the blood circulating through the eye. As a result, the photoreceptor cells of the macula lose access to adequate blood flow and enter a dormant, toxic state and become unresponsive to light. If normal retinal cellular metabolism is not restored, the cells die, and visual acuity is permanently lost. Therefore, it is believed that microcurrent stimulation will help rejuvenate retinal cells to slow or stop degeneration and, in many cases, trigger regeneration of retinal cells in the eye due to AMD.

While microcurrent stimulation therapy has been used to treat AMD and other visual system diseases, the procedures and devices used in the prior art do not appear to maximize the therapeutic effect. Clinical studies have shown that with an appropriate microcurrent stimulation waveform and therapeutic procedure, AMD can be slowed or stopped in a large number of people suffering from the disease, and in some groups of patients, vision can be restored. However, the effectiveness of these therapies can be compromised by the manual techniques medical professionals use to deliver the therapy, or by the inefficient design and function of the medical device. When patients have significant skin impedance or poor electrical conductivity, stimulation level uptake is limited, and this can limit treatment effectiveness.

The present invention includes a disposable adhesive therapy apparatus that replaces the need for lengthy manual applications of microcurrent electrostimulation therapy currently used or envisioned for use by clinicians. Furthermore, the present invention also enables the clinician or physician to administer stimulation to a designated spot on the body, rather than a broader or more comprehensive area of the body. Conventional technologies have two major drawbacks. First, when stimulation is administered with a conventional probe or pointer, the probe or pointer is manually applied to the patient's skin, requiring a significant amount of time from the physician to administer the stimulation and deliver it properly. Second, when a conventional gel strip or semicircle or circles are used in any type of electrostimulation or microcurrent therapy, the gel strip or semicircle or circles cover and administer stimulation affecting a broad portion of the human body, generally more than 20 millimeters in width. These conventional gel strips, semicircles, or circles do not allow for the delivery of stimulation to a "precise" area of two to fifteen (2-15) millimeters in diameter. Rather, the present invention allows for the stimulation of a sequence of such "precise" areas, and the present invention may, in certain treatment therapies, be more effective due to a higher level of stimulation delivered over a smaller surface area, which penetrates more deeply and improves treatment performance.

Figure 1A is a front view schematic diagram of a disposable therapy apparatus strip system 101 having four disposable adhesive curved linear therapy strips 115 placed on the upper and lower eyelids of the left and right eyes of a person 99, showing exemplary positions of the electrodes 111 and connections to the treatment control apparatus 190.

In some embodiments, for each disposable adhesive curved linear therapy strip 115, each electrode 111 of a plurality of individually activatable electrodes 111 is coated with an electrically conductive gel and surrounded by an electrically insulating adhesive, so that when an electrical signal is applied to a selected first electrode 111, current enters the tissue of the patient 99 only beneath that first electrode (and, in some embodiments, one or more other electrodes 111) when the signal from the treatment control apparatus 190 is active at the first electrode (and the one or more other electrodes 111 if those electrodes are also actuated at the time). In some embodiments, the tissue area beneath each of a plurality of electrodes is between about 1 mm2 and about 50 mm2 (e.g., each electrode has electrical contact with the skin in a square of about 1 mm by 1 mm to a square of about 7 mm by 7 mm, or a circle having a diameter of about 1.125 mm to about 8 mm). In some embodiments, each of a plurality of the electrodes 111 on the disposable adhesive curved linear therapy strip 115 has a skin contact area of about 1 mm2 (e.g., a 1 mm by 1 mm square or other suitable shape with that area). In some embodiments, each of a plurality of electrodes 111 on the disposable adhesive curved linear therapy strip 115 has a skin contact area of about 0.75 mm2 (e.g., a 0.866 mm by 0.866 mm square, or a circle having a diameter of about 1 mm, or other suitable shape with that area). Some other embodiments include a plurality of the electrodes 111 on the disposable adhesive curved linear therapy strip 115 wherein each electrode has a skin contact area of between about 1 mm 2 and about 4 mm 2 , a plurality of the electrodes 111 on the disposable adhesive curved linear therapy strip 115 wherein each electrode has a skin contact area of about 4 mm 2 , a plurality of the electrodes 111 on the disposable adhesive curved linear therapy strip 115 wherein each electrode has a skin contact area of between about 4 mm 2 and about 9 mm 2 , a plurality of the electrodes 111 on the disposable adhesive curved linear therapy strip 115 wherein each electrode has a skin contact area of about 9 mm 2 , a plurality of the electrodes 111 on the disposable adhesive curved linear therapy strip 115 wherein each electrode has a skin contact area of between about 9 mm 2 and about 16 mm2, a plurality of the electrodes 111 on the disposable adhesive curved linear therapy strip 115 wherein each electrode has a skin contact area of about 16 mm2, and/or a plurality of the electrodes 111 on the disposable adhesive curved linear therapy strip 115 wherein each electrode has a skin contact area of between about 16 mm2 and about 25 mm2 (e.g., a 5 mm by 5 mm square or other suitable shape with that area). In some other embodiments, each of a plurality of electrodes 111 on the disposable adhesive curved linear therapy strip 115 is substantially circular with a diameter of about 1 mm (a skin contact area of about 0.8 mm2), while some other embodiments include a plurality of substantially circular electrodes 111 each with a diameter of about 1.28 mm (a skin contact area of about 1 mm2), a plurality of substantially circular electrodes 111 each with a diameter of about 2 mm (a skin contact area of about 3 mm2), a plurality of substantially circular electrodes 111 each having a diameter of about 3 mm (a skin contact area of about 7 mm2), a plurality of substantially circular electrodes 111 each having a diameter of about 4 mm (a skin contact area of about 13 mm2), a plurality of substantially circular electrodes 111 each having each a diameter of about 5 mm (a skin contact area of about 20 mm2), and/or a plurality of substantially circular electrodes 111 each having a diameter of about 6 mm (a skin contact area of about 28 mm2). In some embodiments, each electrode is no larger than 50 mm2 (e.g., each electrode has a size of a square of about 7 mm by 7 mm, or a circle having a diameter of about 8 mm) and wherein the strip is shaped to be positioned to place electrodes on an upper eyelid and a lower eyelid of the patient's skin, and wherein each of the plurality of electrodes is configured to be individually activated at a time for microcurrent stimulation without activation of any other of the plurality of electrodes during that time. In some embodiments, each electrode is between about 36 mm2 and about 50 mm2. In other embodiments, each electrode is no larger than 36 mm2 (e.g., each electrode is sized as a square no larger than about 6 mm by 6 mm, or a circle having a diameter no larger than about 6.75 mm). In some embodiments, each electrode is between about 25 mm2 and about 36 mm2. In other embodiments, each electrode is no larger than 25 mm2 (e.g., each electrode is sized as a square no larger than about 5 mm by 5 mm, or a circle having a diameter no larger than about 5.6 mm).

In some embodiments, each disposable therapy apparatus strip 115 includes electrical conductors 114 electrically coupled to the treatment control apparatus 190. In some embodiments, the treatment control apparatus 190 is located locally (e.g., in a battery-operated unit that is carried by a person 99, such as in a shirt pocket or head-mounted elastic band), while in other embodiments, the treatment control apparatus 190 is attached to or is part of a computer-controlled apparatus such as a portable personal computer, a tablet computer, a desktop computer, or the like. Therapy signals from the signal source 190 are carried by the connecting wire bundle 114 to the electrodes 111, which deliver the current charge to the patient's tissue.

Figure 1B is a front view of a system 102 showing an eye having two disposable therapy device strips 115, each placed on the upper and lower eyelid of a person's eye 98, showing exemplary electrode positioning and connections to a microcurrent stimulation controller device 161.

In some embodiments, the microcurrent stimulation controller apparatus 161 includes a battery-operated microprocessor (gP), and is optionally controlled and/or programmed by a nearby portable personal computer, tablet computer, desktop computer, or the like. In some embodiments, each disposable therapy apparatus strip 115 includes electrical leads 114 electrically coupled to an electrical connector 117 that plugs into or otherwise electrically connects to a corresponding connector 162 on the controller apparatus 161.

Figure 1C is a side cross-sectional view of a disposable therapy apparatus strip 115. As noted above, in some embodiments, each of a plurality of individually activatable electrodes 111 is coated with an electrically conductive gel and surrounded by an electrically insulating adhesive, so that when an electrical signal is applied to only a selected first electrode 111, current enters the patient's tissue 99 only beneath that first electrode. In some embodiments, only one selected electrode 111 is activated (actuated by a pulsed electrical signal) at any time, and each of a plurality of the electrodes 111 is sequentially actuated by temporally separated pulses. In some embodiments, two or more of a plurality of electrodes 111 are actuated by simultaneous pulses or by pulses that at least partially overlap in time. In some embodiments, each or a plurality of electrode subsets are tested to determine which are most effective at alleviating symptoms and/or which, when driven by pulsed signals, may cause worsening of symptoms. Based on the empirical results of such electrode subset testing, the system (e.g., system 102 of Figure 1B) selectively activates electrode assemblies 111 and pulse sequences that have been empirically determined to be effective and prevents activation of electrode assemblies 111 and pulse sequences that have been empirically determined to worsen symptoms. The connecting wire bundle 114 (e.g., a wire having a plurality of electrical conductors) is shown leading to the strip substrate 112 containing the electrodes 111.

Figure 1D is an enlarged schematic cross-sectional view of a disposable therapy apparatus strip subsystem 140 including the therapy apparatus strip 145 and the peel-off cover 116. In some embodiments, the disposable therapy apparatus strip 145 includes electrodes 111 that are equivalent to those of the disposable therapy apparatus strip 115 described above, however, the disposable therapy apparatus strip subsystem 140 further includes one or more light-emitting features 122 (such as light-emitting diodes (LEDs) mounted in or on the disposable therapy apparatus strip 145, or light-conducting optical fibers connected to the LEDs on the microcurrent stimulation controller apparatus 161 or the treatment control apparatus 190 described above) and/or one or more vibration units 121. In some embodiments, the light emitting features 122 are activated to emit pulses of light concurrently with applying electrical treatment signals to one or more electrodes 111 to provide feedback to the patient 99 and/or the healthcare professional monitoring the procedure, in order to provide them with feedback to indicate that the procedure is in progress. In some embodiments, the vibration units 121 are activated to gently vibrate the eyelids of the patient 99 concurrently with applying electrical treatment signals to one or more electrodes 111 to provide feedback to the patient 99, in order to provide them with feedback to indicate that the procedure is in progress. In some embodiments, the therapy apparatus strip subsystem 140 includes the optional addition of one or more motors 121 and/or one or more LEDs 122 for feedback. In some embodiments, the LEDs provide a visually perceptible indication of the operation of the therapy strip 145 as feedback to the patient 99 and/or the medical professional supervising the treatment that the device is operating and/or an indication of which therapy protocol (e.g., one of a plurality of selectable protocols) is being applied and/or an indication of how much time remains in the current session (or how much time has elapsed since the start of the current session). In some embodiments, the one or more motors 121 drive an unbalanced shaft that provides a tactile vibration to the patient's eyelid. In some embodiments, the one or more light emitters 122 on the strip indicate, via a single light or multiple lights, what the status of the apparatus is: off, during treatment, intermittent connections, inappropriate electrical impedance and/or insufficient stimulation, and/or therapy progress status (e.g., whether the session is 1/4, 1/2, 3/4, or 7/8 complete). In some embodiments, the light from the LEDs 122 is visible through the patient's closed eyes to indicate that the therapy session is "in treatment and working," or if the session is over. In some embodiments, the light output from the LEDs 122 is also externally visible, so that the physician can assess the status of the treatment therapy session on a patient-by-patient basis without reference to a display screen on the base station 790. In some embodiments, applying an amount of microcurrent at one of the electrodes (e.g., in some embodiments, about 200 microamps or more may cause some patients to perceive a microcurrent-caused flash of light and/or a vibration sensation) of the applied microcurrent in and around the eye, even in the absence of LED light emission from the LEDs 122, and thus light emission from the LEDs 122, and/or vibration from the motors 121, may be used to mask to the patient whether or not microcurrent pulses were applied across one of the electrodes 111. In order to test the efficacy (where efficacy may be defined as the performance of a therapy under ideal, controlled circumstances) and/or the effectiveness (where efficacy refers to the performance of the therapy under "real-life" conditions) of the pulsed microcurrent therapy, it may be useful to deliver to a subset of patients an actual therapy in conjunction with the light from the LEDs 122, and/or the vibration of the motors 121 while a different subset of patients are receiving sham or placebo therapy with the difference (between the actual and sham sessions) masked from the patient as well as from the medical professional monitoring the treatment via the light from the LEDs 122, and/or the vibration of the motors 121 (i.e., using double-blind experiments). In some embodiments, the conductive gel 118 on each electrode 111 is kept moist and separate from the gel 118 on other electrodes 111 by the cover 116 until the therapy apparatus strip 140 is prepared for use by removing the cover 116, thereby exposing the gel 118.

Figure 1E is an enlarged schematic cross-sectional view of a disposable therapy strip 145, (i.e., a disposable therapy apparatus strip subsystem 140 with the peel-off cover 116 removed) connected to a microcurrent stimulation controller apparatus 161 to form the therapy system 146. This therapy system 146, in contrast to just the therapy apparatus strip 145 of the therapy apparatus strip subsystem 140, includes the addition of the microcurrent stimulation controller apparatus 161 connected by the signal cable 114, wherein the controller 161 drives the light signal 131, which goes to the operator, and the light signal 132, which goes to the patient 99 (e.g., in some embodiments, through the patient's eyelid).

Figure 1F is an enlarged front schematic view of a disposable therapy system 146. As noted above, one or more light emitting features 122 and/or one or more vibration units 121 are provided on each disposable therapy apparatus strip 145. In some embodiments, an LED 122 is provided for each electrode 111 and each LED 122 is activated at the same time as the corresponding electrode 111. In some embodiments, each LED 122 is located adjacent to, or directly above or below, the corresponding electrode 111. This view of the device 140 also shows the connector 117 for the wire bundle 114.

Figure 1G is an enlarged cross-sectional schematic view of a disposable therapy apparatus strip subsystem 160 including therapy apparatus strip 165.

In some embodiments, the disposable therapy device strip subsystem 160 is a single-use product that includes a microprocessor and battery unit 161 incorporated into the disposable therapy device strip subsystem 160. In some embodiments, the battery in the unit 161 is air activated through the vent 163 and removal of the removable protective cover 116 from the air barrier activates the battery by allowing air to enter the vent 163. In some embodiments, an auxiliary disposable therapy apparatus strip 145 (i.e., a strip without the built-in microprocessor and battery unit 161 that is applied to one eyelid) may be connected to an activated disposable therapy apparatus strip 160 attached to the other eyelid such that the single microprocessor and battery unit 161 controls operation (sends treatment signals to, and receives feedback signals from, the electrodes 111, the LEDs 122, and/or the vibration units 121) in both the disposable therapy apparatus strip 165 and the connected disposable therapy apparatus strip 145. In some embodiments, the microcurrent stimulation controller apparatus 161 is attached to (and forms part of) the strip 112, with an air vent 163 passing through the substrate 112 to allow air to contact and activate the battery in the controller apparatus 161. In some embodiments, the controller apparatus 161 is actively controlled wirelessly, during operation (e.g., using protocol and circuitry such as Bluetooth®, near field communications (NFC), or the like) from a nearby computer (such as a tablet, desktop, or laptop computer), while in other embodiments, the controller apparatus 161 is similarly wirelessly programmed prior to operation and then operates autonomously in accordance with the program. In some such embodiments, the controller apparatus 161 transmits, back to the nearby computer, sensed signals that are then used to determine therapy efficacy and/or to control the therapy stimulation signals. In some embodiments, the sensed signals transmitted to the nearby computer include sensed electrical impedance measurements for safety monitoring and control, and/or sensed nerve electrical signals, sensed from the patient's skin, that might indicate discomfort or pain of the patient and are then used to limit stimulation signals that would cause such a reaction in the patient. In some embodiments, one or more of the electrodes 111 not currently being used to deliver therapy stimulation signals are instead used to sense nerve electrical signals from the patient's eyelid and to deliver the sensed signals to a connected controller apparatus.

Figure 2C and Figure 3C are described below.

Figure 2A is a front view schematic diagram of a disposable partially surrounding eyestrip system 201 utilizing, on each eye, a single partially surrounding eyestrip 215 with upper and lower eyelid electrodes showing the position of the electrodes 111 and the lead 114 to a microcurrent stimulation controller apparatus (not shown here, see Figure 1A for an example). In some embodiments, a single partially surrounding eyestrip 215 is functionally the same as a pair of curved linear therapy strips 115 as described for Figure 1A, however, a single partially surrounding eyestrip 215 provides the advantage that the upper eyelid portion and the lower eyelid portion automatically align with each other, and the connections to the current stimulation controller apparatus are simpler. The various reference numerals in Figure 2A are as described above for Figure 1A.

Figure 2B is an enhanced detail view of the eye of the disposable apparatus partially surrounding the ocular strip 215 placed on the upper and lower eyelid showing the position of the electrodes and the connections to the microcurrent stimulation controller apparatus.

In some embodiments, the single connector 217 shown here replaces the two connectors 117 of Figure 1B. The other various reference numerals in Figure 2B are as described above for Figure 1B.

Figure 2C is a side cross-sectional view of a disposable partially surrounding therapy apparatus strip 265, including a microcurrent stimulation controller apparatus 161 on the strip 265. The other various reference numerals in Figure 2C are as described above for Figure 1G.

Figure 3A is a front view schematic diagram of two single-strip surrounding disposable therapeutic strips 315 forming a system 301.

In some embodiments, each of the disposable therapy strips 315 is functionally the same as a pair of curved linear therapy strips 115 as described for Figure 1A, or a single partially encircling eye strip 215, but each of the disposable therapy strips 315 provides the advantage that the upper eyelid portion and the lower eyelid portion automatically align with each other at both ends. The various reference numerals in Figure 3A are as described above for Figure 2A.

Figure 3B is an enhanced detail view of the disposable eye-circling therapy strip 315 placed on the upper and lower eyelid showing the position of the electrodes and the connections to the microcurrent stimulation controller apparatus.

In some embodiments, the single connector 317 shown here replaces the two connectors 117 of Figure 1B. The other various reference numerals in Figure 3B are as described above for Figure 1B.

Figure 3C is a side cross-sectional view of a disposable therapy strip 365, including a microcurrent stimulation controller apparatus 161 included in the strip 365. The other various reference numerals in Figure 3C are as described above for Figure 1G.

Figure 4A is a rear view schematic diagram of an electrode-containing eyeglass frame 401 having two surrounding frame members 410, each of which has a plurality of electrodes 111 positioned in strips on the periphery of each frame member 410. In some embodiments, the eyeglass frame 401 includes mechanical connectors 421 and 422 at the temple tips of the elastic side members 420 that provide an adjustable length fastening mechanism for comfortably holding the frame members 410 against the orbital bone and/or eyelids of the patient, and an elastic (elastic) bridge 414 that provides an adjustable interocular distance between the left and right eyes of the patient. In some embodiments, each of a plurality of conductors in the cable 114 is electrically connected to a corresponding one of the plurality of electrodes 111. In some embodiments, each surrounding frame member 410 differs from the single surrounding strip disposable therapy strips 315 in that no adhesive is used to hold the electrodes against the patient's eyelids; rather, the elastic side members 420 wrap around the patient's head to snugly hold the electrodes 111 against the patient's skin around the patient's eyes. The absence of adhesive is an advantage in removing the electrodes from the patient compared to, for example, removing two surrounding single strip disposable therapy strips 315 from a system 301. The absence of adhesive is also an advantage for patients who may be allergic or sensitive to adhesive.

The other various reference numerals in Figure 4A are as described above for Figure 3A.

Figure 4B is a rear view schematic diagram of an eyeglass frame 402 containing electrodes having two strips 412 surrounding the eye that conform to the face.

Figure 4C is a top side view schematic diagram of the eyeglass frame 402 having two surrounding straps 410 that conform to the face.

In some embodiments, the eyeglass frame 402 includes a two-part rigid frame member 433 having a resilient bridge connector 414 that flexibly and resiliently holds the two parts together while providing the stretchability to vary the distance to match the patient's eyes. In some embodiments, each face-conforming eye-encircling strip 412 is positioned on a flexible, compressible elastic extension 431 that extends rearwardly (toward the patient's face) from a corresponding base 432 that is attached to the two-part frame member 433. The flexible, compressible elastic extension 431 allows each eye-encircling strip 412 to better conform to the patient's face. In some embodiments, a wire 114 (which connects to, or extends as, electrical wiring within the eyewear frame 402 containing electrodes for connecting to the electrodes 111) extends from one or both sides of the two-part frame member 433, and conducts electrical stimulation and/or sensing signals between an external controller (not shown here) and the electrodes 111. In some embodiments, each eye-surrounding strip 412 is more flexible than the surrounding frame member 410, and again differs from the single-strip surrounding disposable therapy strips 315 in that no adhesive is used to hold the electrodes against the patient's eyelids; rather, elastic side members 420 wrap around the patient's head to snugly hold the electrodes 111 against the patient's skin around the patient's eyes. The other various reference numerals in Figure 4B and 4C are as described above for Figure 4A.

Figure 5A is an exploded top side view schematic diagram of an eyeglass frame 560 having two disposable adhesive strips 511 surrounding the eyes that have not yet been joined together.

In some embodiments, the adhesive on the removable and replaceable eye-encircling strips 511 is on the frame side (not the side touching the patient's face) and adheres the eye-encircling strips 511 to the surface 512 on the elastic cups 531. In some embodiments, the electrical connectors 541 on the strips 511 electrically connect to mating cup-side connectors 542 on the surface 512 of the flexible compressible elastic extension 531. As with the device of Figures 4B and 4C, in some embodiments, the eyeglass frame 561 includes a two-part rigid frame member 533 having an elastic bridge connector 534 that flexibly and resiliently secures the two parts of the frame member 533 to each other, while providing stretchability to vary the eye-to-eye distance between the two parts to match the patient's eyes. In other embodiments, the frame 533 is a single rigid piece (omitting the elastic bridge connector 534) and flexible compressible elastic extensions 531 provide lateral eye-to-eye distance compensation. In some embodiments, each face-conforming eye-surrounding strip receiving surface 512 is positioned on a flexible compressible elastic extension 531 that extends rearwardly (toward the patient's face) from a corresponding base 532 that is attached to the frame member 533. The flexible compressible elastic extension 531 allows each eye-surrounding strip 511 (which is adhered to the flexible surface 512) to better conform to the patient's face. In some embodiments, each eye-surrounding strip 511 includes a double-sided pressure-sensitive adhesive coated foam layer 518 adhered on one side to a hypoallergenic substrate 517 upon which are deposited a plurality of electrodes 111, each individually electrically connected by a conductor (also deposited on the substrate 517) to a separate corresponding contact on the electrical connector 541. In some embodiments, a first release protective layer on the frame side of the double-sided pressure-sensitive adhesive coated foam layer 518 is removed so that the eye-surrounding strip 511 can be stuck (adhered) to the strip-receiving surface 512. In some embodiments, a small globe of electrically conductive gel is deposited on each electrode 111, and a second peelable adhesive coated protective layer is provided on the patient's skin side of the strip 511 surrounding the eye covering the electrodes 111 and the gel, wherein the second peelable protective layer keeps each gel globe on its corresponding electrode 111 and separated from neighboring electrodes until the second peelable protective layer is removed immediately prior to use. In some embodiments, a vibration motor such as the vibrator 121 of Figure 1D is incorporated into the disposable strip 511. In some embodiments, one or more LEDs 122 (such as those in Figure 1D) are incorporated into the disposable strip 511. In some embodiments, a vibration motor such as the vibrator 121 of Figure 1D is instead incorporated into the eyeglass frame 560 rather than being part of the disposable strip 511. In some embodiments, one or more LEDs 122 (such as those in Figure 1D) are instead incorporated into the eyeglass frame 560 instead of being part of the disposable strip 511.

In some embodiments, a controller 161 (e.g., a microprocessor (optionally including an RF (radio frequency) transceiver that communicates with a remote PC (personal computer), tablet, laptop, or the like) and a battery) is mounted on, or is incorporated into and part of, one side or both sides of the two-part frame member 533, and conducts electrical stimulation and/or sensing signals between an external controller (not shown here) and the electrodes 111. In some embodiments, each eye-surrounding strip 511 and its mounting surface 512 is more flexible than the eye-surrounding frame member 410 of Figure 4A, and again differs from the single-strip surrounding disposable therapy strips 315 in that no adhesive is used to hold the electrodes against the patient's eyelids; Rather, in some embodiments, an elastic band (not shown here, but similar to band 662 of Figure 6A) is wrapped around the patient's head to firmly hold the electrodes 111 against the patient's skin around the patient's eyes (e.g., on the upper and lower eyelids, and/or on the supraorbital bone (the supraorbital foramen of the frontal bone of the skull) and/or the infraorbital bone (the front of the zygomatic bone and/or the maxilla)).

Figure 5B is an assembled top side view schematic diagram of an assembled eyeglass frame 562 having two disposable adhesive strips 515 surrounding the eyes.

In some embodiments, the two disposable adhesive eye-surrounding strips 515 are removably adhered to the mounting surfaces 512 of the eyeglass frame 561, and the electrical contacts 541 and 542 are connected to each other. Note that the reference numeral 515 refers to each eye-surrounding strip 511 after it is adhered and electrically connected to the eyeglass frame 561, and the reference numeral 562 refers to the combination of the eyeglass frame 561 after the two eye-surrounding strips 511 are adhered and electrically connected to the eyeglass frame 561. In some embodiments, a small amount of electrically conductive gel is deposited on each electrode 111. In some embodiments, a through-hole opening through the entire eyeglass frame 561 is left in front of each of the patient's eyes (wherein one of the adhesive strips 515 surrounding the eye surrounds each of these through-hole openings) so that the patient can see the surrounding environment during the therapy session, to reduce claustrophobia, fear, or other stressful conditions for the patient. In other embodiments, a translucent or opaque cover is provided to encourage the patient to minimize eye movement so that the therapy stimulation pulse sequence continues to stimulate the desired tissue volumes throughout the therapy session. In some embodiments, one or both of the adhesive strips 515 surrounding the eye further include one or more LEDs (such as, for example, LEDs 122 of Figure 1D) that provide the optical indicator function described above, and/or one or more vibration units (such as, for example, vibration units 121 of Figure 1D) that provide the tactile feedback function described above. The other various reference numerals in Figure 5A and 5B are as described above for Figure 4A.

Figure 6A is a front view schematic diagram of a system 601 that includes two individual semi-circle disposable therapy strips 615 that together with the controller 661 and its elastic headband 662 form a system 601.

In some embodiments, the system 601 includes one or more electrodes 641, which are placed in contact with the skin on the patient's neck 99, and are attached to the main device (controller 661) by a conductor (e.g., in some embodiments, a cable) 642. In some embodiments, a nose pad and pad-arm assembly 651 is provided for supporting the controller 661 on the patient's forehead 99 over the patient's eyes 98. In some embodiments, therapeutic electrical stimulation pulses are applied in a sequence (one at a time) to the electrodes 111 on the therapy strips 615 surrounding each eye, wherein the return path (i.e., signal ground) is provided via the electrodes 641 (in some embodiments, one or more electrodes 641 are adhesively coupled to the patient's neck 99; e.g., one on each side of the neck as shown). In some embodiments, uniphasic signals are applied to the ocular electrodes (either all positive voltages with respect to the ground electrodes 614, or all negative with respect to the ground electrodes 614) to accumulate the desired ionic molecules on or near the patient's retinas). In other embodiments, balanced biphasic signals are applied to the ocular electrodes (alternating with some positive voltages and some negative voltages with respect to the ground electrodes 614, or applying differential signals to selected pairs of electrodes 111 without using a ground signal to the ground electrodes 614, and in some such embodiments, the ground electrodes 614 are omitted) to prevent accumulation of unwanted ionic molecules on or near the patient's retinas). In other embodiments, uniphasic or biphasic signals are applied between pairs of electrodes 111, wherein the current is applied between an electrode 111 near one eye (on, for example, the left disposable therapy strip 615) and an electrode 111 near the other eye (on, for example, the right disposable therapy strip 615). In other embodiments, uniphasic or biphasic signals are applied between pairs of electrodes 111, wherein the current is applied between one electrode 111 and another electrode 111 on the same disposable therapy strip 615.

Figure 6B is a plan view diagram of a disposable electrode assembly 660 including a single semi-circular strip disposable therapy strip 615 and a single "ground" electrode 641. In some embodiments, two such electrode assemblies 660 are adhered to the patient 99 at the desired positions; then, a controller unit 661 (e.g., mounted on a headband as shown in Figure 6A, or mounted on eyeglasses (as in Figure 4A, or mounted on a neck-mounted or other suitably positioned controller)) worn by the patient 99 is electrically (and/or optically, in the case where optical fibers couple light from LEDs in the controller unit to emitting points on the therapy strip 615) connected to each unit of the electrode assemblies 660. In some embodiments, the electrode 641 is connected to the device by the lead wire 642. Some embodiments include a connector tab or assembly located between parts of the controller 661 to allow for modular assembly and replacement of parts of the device.

Figure 7 is a schematic block diagram of a therapy system 700 including a controller 701 and electrodes 715. In some embodiments, the therapy system 700 includes the base station 790, the controller 701, the FLASH unit 796, the disposable electrodes 715, and (as needed) disposable ground patches, conductive gel, and cleaning wipes. In some embodiments, the base station 790 is a device, such as a laptop personal computer (PC), tablet, desktop computer, or the like, for selecting parameters, monitoring performance, collecting and storing data, and communicating with the control unit (controller 701). In some embodiments, the controller 701 is a control unit containing the electronics that supplies power to the electrode contacts on the eye. In some embodiments, the electrode contacts are part of a disposable strip, goggles, or an individual probe, or the like. In some embodiments, the 796 FLASH drive is a "USB drive" that includes encrypted data and program code to provide a fixed amount of prepaid therapies for patients, wherein each time a successful therapy is completed, one therapy unit is deducted from the flash drive. In some embodiments, the 796 FLASH drive is a "USB memory stick" that includes encrypted data and program code to provide prescriptions for specific therapies to the patient, wherein each time a successful therapy is completed, one therapy unit is deducted from the flash drive. In some embodiments, once all available therapy unit sessions are completed, the 796 FLASH drive may be discarded and a new prepaid flash drive used. In other embodiments, the FLASH unit 796 is also used to collect and record session data and parameters that can later be analyzed to determine the long-term effectiveness of several different therapy variations, whereby once all available therapy unit sessions are completed, the FLASH unit 796 is returned to the analysis facility and in exchange for the data and a fee per therapy session, a new prepaid flash drive is sent to the treatment facility. In some embodiments, patient identification data is anonymized and encrypted for patient privacy and/or legal requirements, while still maintaining each session with sufficient information to analyze what is working and what is not. In some embodiments, the disposable electrodes 715 include a plurality of electrode contacts in the form of an adhesive strip, a disposable handheld probe tip, or a mask, including, for example, six to twelve contacts (or other suitable number), divided with some on the upper portion of the eyelid and others on the lower portion of the eyelid. In some embodiments, a kit is provided where, in addition to the aforementioned disposable electrodes 715 (contact strips), one or more handheld probe tips and/or goggles and the flash unit, the kit also includes items such as disposable ground patches, conductive gel and cleaning wipes.

In some embodiments, the controller 701 includes a microprocessor 711, a power system (such as a battery, ultracapacitor, or the like) 712 that supplies electrical power to the rest of the controller 701, a current source 713 that is controlled by the microprocessor 711 according to signals from the current and impedance sensor 719, an electrode sequencer 714 that selects, for example, which of six possible electrodes to send the electrical pulse signal to at any given time, as controlled by the microprocessor 711, and these pulses are sent through the electrode connector 716 to the electrode array 715. In some embodiments, the disposable electrode array 715 also includes one or more LEDs (e.g., such as 122 of Figure 1D) embedded in or on the strip, wherein these LEDs are driven by electrical signals sent through the connector 716 and provide a status and patient feedback function to tell the medical professional and/or the patient that the system is operational and active. In other embodiments, one or more status LEDs 717 are located on the controller 701 and emit light to indicate status directly from the controller 701, and/or through optical fibers 726 or the like embedded in or on the strip to emission points on the electrode strip, wherein these LEDs 717 are driven by electrical signals from the microprocessor 711 and, as described above, provide a status and patient feedback function to tell the medical professional and/or the patient that the system is operational and active. In some embodiments, a wireless communications device 718 (such as Bluetooth®, NFC, infrared optical communications, or the like) provides one-way or two-way communications to a base station 790. In some embodiments, the base station 790, in accordance with a prepaid therapy authorization from, for example, the FLASH unit 796, transmits 791 programming information specific to the particular patient, wherein the authorization optionally includes authorization according to a fee that has been paid, as well as patient-specific therapy control information that has been customized for the particular identified patient to be treated this session according to a treatment regimen prescribed by an eye care professional or the like. In some embodiments, session parameters are communicated 792 back to the base station (with parameters such as the actual number, polarity, sequence and intensity of pulses, measured impedance and/or current, indicated discomfort of the patient, and the like). In some embodiments, the system 701 includes a patient-activatable switch (e.g., on the system 701 or via a separate hand switch that is in wireless or wired communication with the system 701) that the patient is instructed to press if and when the patient experiences discomfort or concern, and upon activation of that switch, the electrical output of the system 701 or even the entire system 701 is immediately turned off, and/or the time of the patient's activation of the switch is recorded and transmitted in the session parameters communication 792. Thus, this feedback from the patient themselves is, in some embodiments, used to completely shut down the device (for the patient's comfort and peace of mind, as well as for further enhancement of patient safety in case the current source 713 has a fault and is sending too much current), and is then correlated to a particular time or other aspect of the treatment to allow for the design of better therapy sessions in the future, and/or can be used to immediately terminate the session (wherein the microcontroller 711 will immediately switch all connections to "off" (or high impedance) to block any further current to the patient, and/or the entire system 701 is then powered down and disconnected (i.e., after storing the timestamp of the patient's switch press) from the power source (e.g., battery) 712. In some embodiments, the system 701 and/or base station 790 includes an audio output unit 720 that provides a sound (beep, chime, ding, or the like) associated with the status of the therapy session, to indicate, for example, "session start/ON" in therapy, an alert about insufficient or inappropriate treatment, and "session end/OFF".

In some embodiments, the system 700 is a software-driven system that provides programmability of all parameters, including frequency, waveform, current level, therapy duration, and the number of "cycles" around the eye (where, in some embodiments, a cycle is the independent activation of each of the six to twelve electrode contacts). In some embodiments, these parameters are programmed during manufacturing, while in other embodiments, the parameters are field-programmed by the physician or a company representative. In some embodiments, modifications to the programming parameters and/or software (e.g., as customized by a prescription for a treatment protocol provided by a licensed medical professional for a specific identified patient) are stored on a plug-in storage device 796 (such as a USB FLASH storage device or the like) and the parameters and/or program are uploaded (via the plug-in device 796) to the base station 790 (and then transmitted 791 (e.g., wirelessly or via a wired connection) to the system 701 to be stored in the memory of the microprocessor 711). In other embodiments, the pluggable storage device 796 is directly connected to the system 701 to load and store the parameters and/or the program in the memory of the microprocessor 711 (in some such embodiments, the base station 790 is omitted, while in other embodiments, the base station 790 is retained to provide the medical technician/professional with the status of each session in real time). In some embodiments, the base station 790 is used to provide the medical technician/professional with the status of each session of a plurality of simultaneous patient sessions in real time (e.g., in some embodiments, a laptop computer used as the base station 790 is programmed to provide a split-screen progress monitor (e.g., wherein the display screen is divided into, e.g., quadrants if up to four patients were treated simultaneously) for a plurality of treatment sessions for each of a plurality of patients). In some embodiments, the software may also be modified remotely using the wireless connection to the base station 790. In some embodiments, a licensed practitioner prepares and verifies a prescription for a treatment session (the protocol, parameters, and the like to control the amount of current, pulse duration, spacing between pulses, and how many pulses to be sent, and the like) for each individual patient, and this prescription is downloaded and/or stored on the base station 790, or on the USB device 796 along with the prepaid activation code to allow only authorized treatments for specific patients. In some embodiments, the software on the base station 790 and/or the software on the system 701 checks the match between a specific patient's prescription associated with a specific identified patient and the patient identification information of the specific identified patient in order to verify that the correct prescription is used for that patient.

Some embodiments include a large memory in the system 701 and/or the base station to capture and record all pertinent patient and clinic data, including the treatment protocol, such as the number of pulses applied to each electrode, the amount of current, and all other relevant parameters of what the treatment session entails (including, for example, whether an actual or simulated treatment session was provided to the particular patient). In some embodiments, the recorded data is stored in a permanent memory portion of the USB storage device 796 (e.g., using a memory portion that allows only a single write operation that may be followed by many read operations, so that the data is permanently stored and available at a later time). In some embodiments, this data is collected remotely and summarized by company and/or clinic personnel. In some embodiments, the data is summarized to provide comparisons between patients and clinics and may be used in research. Over time, this data will allow the company or testing center to optimize clinical design and protocol, thereby improving outcomes.

Some embodiments provide increased current drive capability via current source 713, as well as improved current and impedance measurements via sensor unit 719. This allows system 701 to deliver higher, more carefully controlled current levels that overcome any unexpected higher impedance levels. In some embodiments, apparatus 700 has a regulator (e.g., current controller) to prevent delivery of more than 350 microamps (pA) to the patient during therapy. In some embodiments, base station 790 and/or system 701 may be triggered only via an appropriately encoded message from flash drive 796, or via an authentic encrypted code (e.g., in some embodiments, received from a company website on the Internet) that allows the laptop to signal, via Wi-Fi in some embodiments, microstimulation controller 711 to conduct the therapy session for a particular identified patient. In some embodiments, the microstimulation controller 711 and system 701 are implemented in the glasses (e.g., unit 161 in Figure 5A), and the apparatus 701 may be activated through a flash drive 796 connected to the system 701 or through any other suitable type of connection (such as a USB cable to the base station 790).

Some embodiments provide automatic adjustment to changes in impedance. As the impedance changes during treatment, from contact to contact and eye to eye, the control unit 701 will automatically adjust to maintain a constant current level. This improves performance and results. Treatment has been automated to minimize physician involvement. The system 700 automatically manages the therapy to ensure consistent and repeatable results.

In some embodiments, the control unit 701 is designed to fit snugly against and connect to the left and right ground pads (e.g., 641 of Figure 6A). This eliminates the possibility of signal loss to the left and right contact set due to patient movement during therapy. The small size of the control unit reduces clutter, improves patient comfort, and enhances device consistency and compliance.

In some embodiments, the control unit is designed to be tamper-proof (both physically and electronically), and to provide encryption on the programming and detected parameters to prevent hacking.

In some embodiments, the base station 790 communicates with the control unit 701 via a wireless connection, eliminating the need to tether the patient to the base station. This improves compliance and makes setup and therapy sessions easier to manage.

In some embodiments, the base station may communicate with multiple control units at once, reducing the number of base stations required, thereby reducing setup time and the physician's time to manage multiple patients.

In some embodiments, multiple levels of protection help ensure that the electrical current delivered to the contacts cannot exceed the programmed current. The design ensures that an unsafe level of current cannot be reached even if the output were shorted (zero impedance). In some embodiments, the control unit 701 is powered by a small direct current (DC) coin cell and is not connected to the base station during therapy, reducing or eliminating the possibility of patient injury.

In some embodiments, the low cost of the design allows most or all of the system to be single-use and disposable.

In some embodiments, the base station may communicate with a device such as an eyeglass device and/or strips that partially or completely surround the upper and lower eyelids, as well as other parts of the body.

Figure 8 is a block schematic diagram of a therapy system 800 including a controller 161 and a plurality of light sensors 811 mounted on an eyeglass frame or eyeglass-type accessory. The other miscellaneous reference numerals in Figure 8 are as described above for Figure 4A. In some embodiments, the plurality of light sensors 811 are used to detect the amount and/or direction of ambient light in the room where therapy is provided, and this data is recorded during some or all sessions, to determine whether or not the ambient light during the session makes any difference in the efficacy or effectiveness of the treatment (i.e., this provides an additional parameter that is recorded, just in case the ambient light during the therapy session affects the outcome and/or if the patient feels less anxiety or boredom during therapy under different ambient light conditions).

In some examples, the present disclosure includes combinations of two or more features individually and/or collectively shown and described above in Figure 1A through Figure 8. A non-limiting example of such a combination is including one or more vibrators, and/or one or more LEDs, and/or one or more electrode contact points in the eyeglass-like accessory of Figure 8. In some other examples, the present disclosure provides sub-combinations that include most of the features of the various embodiments, but omit one or more features individually shown and described above in Figure 1A through Figure 8.

Some examples of the present disclosure include a disposable therapy apparatus that preferably includes a curved linear strip, semicircular strip, or surrounding strip of material containing a plurality of electrodes for applying microcurrent therapy, and optionally one or more sensors and/or other transducers. In some embodiments, the linear, semicircular, or surrounding strip of material is positioned to place electrodes on the upper eyelid and the lower eyelid. In some embodiments, the curved, linear, semicircular, or surrounding strip of material includes a mild adhesive to make the strip adherent to the skin, and/or includes a conductive gel at the electrode contact points. Within or on the linear, semicircular, or surrounding strip are spaced-apart electrodes at specific points that are individually and separately connected to a controller apparatus that generates the prescribed microcurrent in a sequence to the plurality of electrode points on the material. In some embodiments, the microcurrent stimulation controller apparatus to which the disposable therapy apparatus is connected also contains a software system that is programmed to sequence therapy at the various electrode points on the material, and also to detect the patient's electrical impending shock and thereby provide feedback to the controller apparatus to automatically adjust the microcurrent simulation level, in order to deliver the amount of stimulation originally preselected for that treatment session by the physician to achieve enhanced/optimal therapy.

In some embodiments, the disposable therapy device includes one or more threaded "light delivery" filaments or LEDs embedded in or on the strip material to transmit a low-level light signal, indicating to the patient that the device/strip is functioning as intended. This low-level light signal has a selected intensity and spectrum, chosen to penetrate the patient's closed eyelid and be received by the photoreceptor cells operating at the back of the retina. In some embodiments, the light signal will resemble a dull flash or pulse, and may be white light or a special colored light (such as red or green).

In some embodiments, the disposable therapy apparatus includes a vibrating filament threaded through the strip, or a vibrator embedded in or on the strip material or simply connected to the strip, to transmit a gentle level of vibration as the microcurrent stimulation therapy is applied. Again, in some embodiments, this provides the function of conveying to the patient that stimulation is being delivered for those instances where the microcurrent electrostimulation itself is simply not felt by the patient. The benefit of this is that the patient can sense that the system is working and will be more willing to stay still and complete the full treatment session, compared to a session where the patient has no marker to indicate that anything is happening.

In some embodiments, the disposable therapy device is placed and secured to the patient by the attending physician or clinician in the clinic. The patient's eyelid is cleaned with a sterile solution contained in a wipe or similar material. The physician, wearing sterile surgical gloves, then opens the package containing the disposable therapy device(s). In some embodiments, the disposable therapy strips have a peel-to-open backing that is removed just before the user. In some embodiments, the physician then applies the strip(s) as follows:

A) For embodiments implemented as individual curved linear strips: A first strip is placed on the closed upper eyelid, below the eyebrow, across or below the bone of the upper orbital cavity. With the eye closed, a second strip is applied below the eye, along the bone of the lower orbital cavity. If the patient's other eye is to be stimulated, then the individual strips for the second eye are prepared in the same manner. The strips are then connected to the microcurrent stimulation controller to initiate therapy.

B) For embodiments implemented as a semicircular strip: The upper portion of the strip is placed on the closed eyelid, below the eyebrow, across the bone of the upper orbital cavity. With the eye closed, the lower portion of the semicircular strip is applied below the eye, along the bone of the lower orbital cavity. If a second eye is to be stimulated, the second eye is then prepared in the same manner with a second semicircular strip. The strip(s) are then connected to the microcurrent stimulation controller device to initiate therapy.

C) For embodiments implemented as a circular strip: The upper portion of the circular strip is placed on the closed eyelid, below the eyebrow, across the bone of the upper orbital cavity. With the eye closed, the lower portion of the circular strip is applied below the eye, along the bone of the lower orbital cavity. If the patient's other eye is to be stimulated, the second eye is then prepared in the same manner with a second circular strip. The strip(s) are then connected to the microcurrent stimulation controller to initiate therapy.

In some embodiments, when the therapy is complete, a beep, a light illuminates or flashes, and/or another completion indication is provided. The physician then disconnects the strips from the microcurrent stimulation controller generating the microcurrent stimulation. The physician then gently removes the strips (in whatever configuration is used). The strips will be disposed of according to the company's instructions as guided by government directives. The patient's eye is again cleansed with a sterile wipe or gauze.

The advantages of the new technology of the curved linear microcurrent stimulation strip, semi-surrounding strip or surrounding strip of the present invention include:

a. provide a novel electrode apparatus for providing microcurrent stimulation therapy to a body part to combat pain, injury, or chronic disease in that body part;

b. provide a new electrode apparatus to treat various diseases, including macular degeneration and retinitis pigmentosa;

c. providing an electrode apparatus that delivers microcurrent stimulation therapy via a strip, semicircle, or circle of material containing a plurality of electrodes that are individually wired separately to the microcurrent stimulation controller apparatus and are positioned at predetermined, separate locations on the upper and/or lower eyelid with an adhesive material;

d. provide sensors to monitor the current delivered to the various points on the material and adjust the current according to the degree of impedance of the patient's tissue;

e. provide curved linear strips, semicircular strips, or encircling strips, or other strips, semicircles, or circles of material containing various numbers of electrodes that are disposable after each treatment session. In some embodiments, the invention is packaged in a clean or sterile package, depending on requirements, in a barrier or contamination-proof package. Disposability reduces the risk of cross-contamination between patients and eliminates the need to sterilize or clean a handheld probe conventionally used by clinicians to treat patients.

f. optionally include one or more light filaments that can indicate to the patient during the therapy session that the appropriate level of therapy is being delivered to the patient and that they are not experiencing undue impedance.

g. Incorporate a safety feature by separately wiring each electrode or sensor to the treatment device that delivers the electrical stimulation. This design prevents more than one electrode from delivering therapy simultaneously and potentially injuring the patient;

h. that the stimulation is not carried out simultaneously over the entire surface of the treatment strip or semicircle or circle, but is concentrated on specific individual separate sites;

i. determining specific areas of stimulation using the software program of the device connected to the microcurrent strip, circle, or semicircle. The microcurrent strip, circle, or semicircle has specifically located points within the material that can deliver specific timed or sequenced stimulation to different points along the material, in a preset sequence, for a varied or preset amount of time, at a single contact point, or at two or more individual contact points, with preset stimulation levels, unlike a large pad that delivers generalized stimulation over the entire surface of the pad.

j) allowing the physician, via the therapy device and its treatment methodology, to direct stimulation to a particular treatment point (in some embodiments, as small as 1-2 millimeters, or as large as 5-10 millimeters), which improves treatment efficacy as the body may not tolerate a higher current dose at a small delivery point, or it may not be effective if delivered over a larger surface area, such as via a standard gel pad. Furthermore, this stimulation may be delivered to a specifically designed and tolerated treatment point within a timed sequence and then to another in a pre-set pattern designed to optimize treatment outcomes for patients.

Details in some embodiments of the disposable adhesive appliances include one or more of the following:

a) Application to the upper and/or lower part of the eye, as well as other parts of the body.

b) Curved linear microstimulation strips, semicircular strips or wrap-around strips are sterile or clean packaged disposable strips

c) Curved linear microstimulation strips, semicircular strips or surrounding strips are gel-coated and have a perimeter adhesive

d) Curved linear microstimulation strips, semicircular strips, or surrounding strips contain unique contact points that:

i. have between 2-10 contact points on each curved linear strip;

ii. have between 2-20 contact points in semicircular strips or surrounding strips;

iii. does not stimulate the entire electrode array on a pair of curved linear strips, semicircular strips, or surrounding strips; only specific points selected within the stimulation program determined by the physician and programmed into the device;

iv. The contact points may be activated individually (one at a time) or multiple points at once; meaning that in some embodiments, only one contact point may stimulate at a time per eye or body part; or in other embodiments, two or more contact points may stimulate simultaneously, determined by the program mode selected on the apparatus. However, the entire strip, semicircle, or circle is not active with stimulation at any given time; v. The contact points may be sequenced, in a preset pattern determined by the program of the apparatus delivering the stimulation;

vi. The contact points are capable of receiving various levels of stimulation as determined by the device, meaning that the level of stimulation delivered through the various contact points may vary and increase or decrease over the course of the selected treatment program as determined by the device or the physician.

e) Safety Element: The strips rely on a safety regulator integrated into the device (apparatus), so that a single point cannot deliver more than 350 mA of current. The strips have a built-in sensor to monitor the level of stimulation delivered to improve treatment performance. In some embodiments, the sensor also measures the impedance at the stimulation site and adjusts the current through a feedback loop.

f) The strips contain a built-in light filament to indicate stimulation delivery.

g) The strips contain a vibration element designed to indicate the delivery of stimulation.

h) The strips contain a connection element to the main device.

It should be understood that the foregoing description is intended to be illustrative and not restrictive. Although numerous features and advantages of various embodiments as described herein are set forth in the foregoing description, along with details of the structure and function of various embodiments, many other embodiments and changes in details will be apparent to those skilled in the art upon review of the foregoing description. The scope of the invention should therefore be determined with reference to the appended claims.

Claims (15)

1. An apparatus comprising a therapy device (146 or 165 or 265 or 365 or 601) including a controller (161) and a strip substrate (112) containing a plurality of electrodes (111), characterized in that: the strip substrate (112) containing the plurality of electrodes (111) forms a disposable therapy apparatus, wherein the strip substrate has an adhesive for adhering the strip substrate to the skin of a patient and the controller (161) is a microcurrent stimulation controller that is configured to apply microcurrent stimulation therapy to the patient, wherein each electrode (111) is no larger than 50 mm2, wherein the strip substrate (112) is shaped to be positioned to position electrodes (111) on at least one of an upper eyelid and a lower eyelid of the patient's skin for a treatment session, and wherein the controller (161) is configured to activate each of the plurality of electrodes (111) for microcurrent stimulation such that one or more of the plurality of electrodes (111) are selectively activated at a time without activation of any other of the plurality of electrodes (111) during that time. 2. The apparatus of claim 1, wherein the strip substrate (112) includes an amount of conductive gel (118) at a skin contact point of each of the plurality of electrodes (111), the apparatus further including: a removable protective layer (116) that separately encloses each amount of conductive gel so that the amounts of conductive gel do not touch each other when the strip substrate (112) is applied to the patient's skin. 3. The apparatus of claim 1, wherein the electrodes (111) are separated at predetermined location points along the strip substrate (112), and are individually and separately connected to the controller (161), and wherein the controller (161) is configured to generate a prescribed microcurrent supplied to each of the plurality of electrodes (111) in a time sequence. 4. The apparatus of claim 1, wherein the controller (161) is configured to detect electrical impedance between the electrodes (111) and the patient and thereby provide feedback to the controller (161) to automatically adjust the amount of microcurrent simulation, in order to deliver the amount of microcurrent stimulation originally preselected for the patient's treatment session by a physician to achieve improved therapy. 5. The apparatus of claim 1, further comprising: a patient-activatable switch, and wherein the controller (161) is configured to stop the therapy upon activation of the switch. 6. The apparatus of claim 1, wherein the controller (161) is configured to visibly display the status of the treatment session. 7. The apparatus of claim 1, wherein the controller (161) is configured to capture data parameters of the treatment session and to transmit the captured data to a base station for analysis to refine subsequent treatment sessions and to confirm that the apparatus is operating correctly and is being administered correctly, and to ensure consistency of results. 8. The apparatus of claim 1, wherein the controller (161) is configured to adjust the protocol for a treatment session at a clinic via the software system according to a signal received from a remote system via the Internet. 9. The apparatus of claim 1, wherein the controller (161) is configured to adjust the protocol for a treatment session according to data received from a USB-connected storage device (796) directly connected to the controller (161). 10. The apparatus of claim 1, wherein the controller (161) is configured to adjust the protocol for a treatment session according to data received wirelessly from a base station (790) having a USB-connected storage device (796) directly connected to the base station. 11. The apparatus of claim 1, further comprising a vibrator (121) connected to the strip substrate (112) to transmit a gentle level of vibration as the microcurrent stimulation therapy is applied. 12. The apparatus of claim 1, further comprising at least one light emitting device (122) on the strip substrate (112), wherein the strip substrate is transparent or translucent such that light from the at least one light emitting device is visible to both the patient and an external observer. 13. The apparatus of claim 1, further comprising: a plurality of light-emitting devices (122) on the strip substrate (112), wherein each respective one of the plurality of electrodes has an associated one of the plurality of light-emitting devices in proximity to the respective electrode; and a ground electrode (641) connected to the controller (161) via a conductive wire (642), wherein the electrodes are spaced at predetermined location points along the substrate, and are individually and separately connected to the controller (161), wherein the controller (161) is configured to generate a prescribed microcurrent pulse delivered to each of the plurality of electrodes in a time sequence, and wherein the controller (161) is configured to activate the respective associated one of the plurality of light emitting devices during the microcurrent pulse delivered to the respective electrode. 14. The apparatus of claim 1, wherein the electrodes are spaced at predetermined location points along the strip substrate (112), and are individually and separately connected to the controller (161), wherein the strip substrate (112) is shaped to be positioned to place one or more of the plurality of electrodes on the upper eyelid and one or more of the plurality of electrodes on the lower eyelid. 15. The apparatus of claim 1, wherein the strip substrate (112) is formed as a partially surrounding eyepiece strip substrate (215 or 265 or 615) or a surrounding eyepiece strip substrate (315 or 365).